EMA enters third phase of Brexit preparedness business continuity plan

On 1st October 2018, the European Medicines Agency (EMA) entered into the third phase of their Brexit preparedness business continuity plan (BCP). During the third phase, the temporary suspension or decrease in additional activities will enable the EMA to safeguard core activities which are related to the evaluation and supervision of medicines, whilst the Agency acts on the consequences of the United Kingdom’s exit from the European Union (EU) in March 2019.

The EMA expects that phase 3 may have to be complemented with further temporary suspensions and reductions as of 1st January 2019, which will be launched as part of phase 4 of the BCP, so the Agency can put in place the required arrangements for the physical move to the Netherlands.

As part of phase 3 of the BCP, the EMA has released new cut-off dates for UK Rapporteurship appointments for pre- and post-authorisation procedures for centrally authorised products for pre- and post-authorisation activities for centrally authorised medicines (CAPs).

To prepare for the UK’s withdrawal from the EU on 30th March 2019, all medicines for which the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) are currently acting as rapporteurs or co-rapporteurs in centralised procedures, will have to be switched to new rapporteurs and co-rapporteurs from the EU27 Member States, which also includes Iceland and Norway. With regards to full initial marketing authorisation applications, the process is complete and new rapporteurs have been assigned for all CAPs.

All other post-authorisation procedures will be allocated to new (co)-rapporteurs as below:

  • quality, safety and efficacy type II variations submitted after 26th October 2018
  • renewal applications submitted after 24th October 2018
  • periodic safety update reports (CAPS only) submitted after 6th November 2018
  • type IB variations submitted after 16th January 2019.

The EMA would like to remind companies to submit their applications for any changes which allow their marketing authorisations to remain valid in the EU, Iceland and Norway after Brexit “as soon as possible and in consideration of the procedural timelines foreseen in the regulatory framework.”

As of 1st October, all pre-submission meetings for human centralised initial application requests will be held remotely via teleconference or virtual meeting, until the EMA is operational in their new permanent premises at the end of 2019. It is also important to note that no pre-submission meetings for human centralised initial applications will take place between 11th February and 15th March 2019, whilst the EMA physically moves to their new premises in Amsterdam.

To read more about the EMA’s Brexit preparedness, please click here.